Social communication intervention for young children with Down syndrome
| ISRCTN | ISRCTN13902755 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13902755 |
| IRAS number | 252332 |
| Secondary identifying numbers | IRAS 252332, CPMS 43910 |
- Submission date
- 31/07/2020
- Registration date
- 25/08/2020
- Last edited
- 07/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Genetic Diseases
Plain English Summary
Background and study aims
Down syndrome (DS) is a relatively common genetic condition which affects about 1 in every 700 babies. DS is the most common cause of learning disability. Children with DS have particular difficulties with speech and language. This makes it difficult for them to participate fully in life, access healthcare services and educational opportunities. As DS is detected before or at birth, support can be provided from early on. There are currently no standard interventions for improving the language skills of young children with DS. Existing
research suggests that the earlier an intervention is carried out, the better the outcomes. Evidence suggests that early parent-based interventions might be effective in improving language. Preliminary work shows that an intervention focusing on early social communication skills (e.g. the child’s ability to share focus of attention with an adult) can lead to better language in children with DS. Parents who participated in the preliminary study reported an overwhelmingly positive effect of the intervention on their children's communication. Improving the language skills of young children with DS is vital for their future social and emotional well-being and behaviour, and consequently contribution to society. The aim is to carry out a feasibility study to inform a future pilot/full trial to test whether the intervention is effective in improving language skills before children with DS start school. The feasibility study will establish whether the researchers can recruit enough children and parents through NHS Trusts for a full-sized trial, how acceptable a parent-led intervention would be for parents and speech and language therapists, and provide information on how to run a full trial.
Who can participate?
Children with Down syndrome aged between 12 and 23 months and their parents/carers
What does the study involve?
The parents receive an intervention manual which they need to follow. The sessions involve structured activities with the child playing with toys. During the parent-led intervention period, the parent can access their child’s speech and language therapist (over the phone) and designated members of the research team for support. The parent will need to complete questionnaires about their child's development and also parental health and wellbeing at three timepoints (before and after the intervention, and 6 months later).
What are the benefits and risks of participating?
By taking part, parents and their children with Down syndrome will help to build the evidence base of improving children’s communication skills to help others. The researchers don’t foresee any disadvantages to the children or parents/carers.
Where is the study run from?
University of Reading (UK)
When is the study starting and how long is it expected to run for?
August 2019 to March 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof Vesna Stojanovik
v.stojanovik@reading.ac.uk
Contact information
Scientific
School of Psychology and Clinical Language Sciences
University of Reading
Reading
RG6 6AL
United Kingdom
 ORCID ID |
0000-0001-6791-9968 |
|---|---|
| Phone | +44 (0)118 3787456 |
| v.stojanovik@reading.ac.uk |
Study information
| Study design | Multi-centre mixed methods randomized controlled feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet. |
| Scientific title | Evaluating an early social communication intervention for young children with Down syndrome: a feasibility study |
| Study acronym | ASCEND |
| Study hypothesis | Supplementing standard speech and language treatment with a parent-led early social communication intervention, focusing on shared attention, will improve the language skill of children with Down syndrome (DS). |
| Ethics approval(s) |
1. Approved 04/08/2020, South Central Berkshire Research Ethics Committee (Ground Floor, Skipton House, 80 London Road, London, SE1 6LH, United Kingdom; +44 2071048129; berkshire.rec@hra.nhs.uk), ref: 19/SC/0572 2. Approved 27/04/2020, University of Reading Research Ethics Committee (Academic and Governance Services, Whiteknights House, PO Box 217, Reading, RG6 6AH, United Kingdom; +44 118 3787119; urec@reading.ac.uk), ref: UREC 20/15 |
| Condition | Down syndrome |
| Intervention | The intervention focuses on developing the child's social communication skills through a structured play for which a manual and toys are provided. Randomisation: Once informed consent has been given and baseline assessments have been completed, participants will be randomised to receive standard care (Control) or standard care plus the intervention (Intervention). Randomisation will be achieved using a secure web-based randomisation platform, SortitionTM provided by the University of Oxford. Intervention: Parents/guardian will be provided with an intervention manual (paper-based) with explanation and brief training. Parents/guardian will be advised to progress through the stages of the intervention step by step and practice three times a week for 10 weeks. Support to deliver the intervention from the child’s Speech and language therapist (SLT) will be available at the request of parents by telephone/email. SLTs may provide support by telephone/email or face to face as needed. The SLT will record all contacts from parents in the child’s case notes including the duration and content of each contact. Two telephone calls from the PI, one at week 4 and the second at week 8. |
| Intervention type | Behavioural |
| Primary outcome measure | Language (expressive and receptive) measured using a well-established parental questionnaire (Communicative Development Checklist) pre-intervention, immediately post intervention and at 6 months follow up. |
| Secondary outcome measures | Responding to joint attention as measured by the Communication and Symbolic Behaviour Scales (also a parental questionnaire) measured pre-intervention, immediately post and at 6 months follow up. |
| Overall study start date | 01/08/2019 |
| Overall study end date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient, Health professional, Other |
|---|---|
| Age group | Child |
| Lower age limit | 11 Months |
| Upper age limit | 36 Months |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 19 |
| Participant inclusion criteria | 1. Parent or guardian willing and able to provide informed consent on behalf of participant 2. Confirmed diagnosis of trisomy 21 (DS) 3. Male or female child, 12 to 23 months old at study entry 4. Parent/carer giver has the literary and language skills needed to use intervention manual 5. The participant has not previously been entered into this study 6. The child is not currently taking part or planning to take part in a language based interventional study |
| Participant exclusion criteria | 1. Children with co-morbid conditions (for example Down syndrome and Autism Spectrum Disorder) as determined by the PI 2. Any reason in the opinion of the Principal Investigator that the child is not suitable for study participation |
| Recruitment start date | 01/09/2020 |
| Recruitment end date | 30/06/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Marsh Way
Rainham
London
RM13 8GQ
United Kingdom
Sponsor information
Hospital/treatment centre
Fitzwilliam House
Skimped Lane Hill
Bracknell
RG12 1BQ
England
United Kingdom
| Phone | +44 (0)7767 481 879 |
|---|---|
| Stephen.Zingwe@berkshire.nhs.uk | |
| Website | http://www.berkshirehealthcare.nhs.uk/ |
"ROR" |
https://ror.org/03t542436 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The study protocol has been published. The study results are expected to be published in Pilot and Feasibility Studies. |
| IPD sharing plan | Data are available through the University of Reading repository https://doi.org/10.17864/1947.000470 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 17/01/2022 | 22/08/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Preprint results | 25/08/2023 | 23/10/2023 | No | No | |
| Dataset | 07/10/2024 | No | No | ||
| Results article | 05/10/2024 | 07/10/2024 | Yes | No |
Editorial Notes
07/10/2024: Publication reference and dataset added.
23/10/2023: The following changes were made to the trial record:
1. The ethics approval was added.
2. The participant type was changed from 'mixed'.
3. The participant level data sharing statement was added.
4. Publication reference added.
13/04/2023: The following changes have been made:
1. The study website has been added.
2. The participant type has been changed from ‘Patient’ to ‘Mixed’.
3. The final enrolment number has been added.
4. The publication and dissemination plan has been changed from "The study protocol is available from Prof Vesna Stojanovik (v.stojanovik@reading.ac.uk). Planned publication of the study results in a high-impact peer-reviewed journal." to "The study protocol has been published. The study results are expected to be published in Pilot and Feasibility Studies."
5. The intention to publish date has been changed from 30/04/2023 to 31/10/2023.
31/01/2023: Contact details updated.
16/12/2022: The intention to publish date was changed from 31/12/2022 to 30/04/2023.
22/08/2022: Publication reference added.
15/06/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/01/2022 to 31/03/2022.
2. The intention to publish date was changed from 01/06/2022 to 31/12/2022.
3. The plain English summary was updated to reflect these changes.
19/04/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2021 to 30/06/2021.
2. The overall end date was changed from 31/07/2021 to 31/01/2022.
3. The intention to publish date was changed from 31/12/2021 to 01/06/2022.
4. The plain English summary was updated to reflect these changes.
25/08/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).
